Effect of Supplementation With Vitamin D on the Acute Bronchitis Prevention During the First Year of Life

Upper Respiratory Tract Infection Clinical Trial

— VitDBR2012  

Official title:

Effect of Supplementation With Vitamin D on the Acute Bronchitis Prevention During the First Year of Life

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01875757
• Other study ID #: 2012-001152-19
• Secondary ID: 2012-001152-19
• Status: Completed
• Phase: Phase 3
• First received: June 10, 2013
• Last updated: March 21, 2017
• Start date: November 2013
• Est. completion date: December 2016

Study information

• Verified date: March 2017
• Source: Hospital Universitari Vall d'Hebron Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A phase III multicenter randomized double blind clinical trial will be conducted. After obtaining written consent the infant will be randomized, during the first two weeks of life, to a study group to receive either 400 IU or 1,000 IU / day of vitamin D to the year of age.

Baseline and all follow up visits (2, 6, and 12 months of life) will include anthropometric measurements and a questionnaire about health issues. A blood sample will be obtained at baseline for analysis of 25OH vitamin D, and at 6 and 12 months for analysis of 25 OH vitamin D, and calcium.

Healthy term born infants of appropriate size for gestational age will be included. We will need to include 359 children in each group.

The primary objective of the study is to decrease the proportion of infants with acute bronchitis during the first year of life by supplementation of 1,000 IU/day vitamin D. Secondary otcomes are: To check that the administration of 1,000 IU/day vitamin D decreases the proportion of infants with upper respiratory tract infections, the proportion of children under one year of age hospitalized for acute bronchiolitis, and the demand on the healthcare system due to respiratory infections and absences from work for parents and achieves a higher proportion of children with adequate blood levels 25 OH vitamin D.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 19 Days

Eligibility

Inclusion Criteria:

• Healthy term born infants of appropriate size for gestational age

• Parents provide informed consent to participate

Exclusion Criteria:

• Infants with small size for gestational age

• Infants with gestational age < 37 weeks

• Infants with congenital anomalies

• Infants with chronic gastrointestinal tract, liver, kidney, heart, or neurological diseases

• Infants with disorders of vitamin D or calcium metabolism or others inborn errors of metabolism

Related Conditions & MeSH terms

• Acute Bronchiolitis
• Acute Bronchitis
• Acute Disease
• Bronchiolitis
• Bronchitis
• Respiratory Tract Infections
• Upper Respiratory Tract Infection

Intervention

Drug:
• Vitamin D3

• Placebo

Locations

Country	Name	City	State
Spain	Hospital Universitary Vall d'Hebron	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitari Vall d'Hebron Research Institute

Country where clinical trial is conducted

Spain, 

References & Publications (6)

Belderbos ME, Houben ML, Wilbrink B, Lentjes E, Bloemen EM, Kimpen JL, Rovers M, Bont L. Cord blood vitamin D deficiency is associated with respiratory syncytial virus bronchiolitis. Pediatrics. 2011 Jun;127(6):e1513-20. doi: 10.1542/peds.2010-3054. — View Citation

Camargo CA Jr, Ingham T, Wickens K, Thadhani R, Silvers KM, Epton MJ, Town GI, Pattemore PK, Espinola JA, Crane J; New Zealand Asthma and Allergy Cohort Study Group.. Cord-blood 25-hydroxyvitamin D levels and risk of respiratory infection, wheezing, and asthma. Pediatrics. 2011 Jan;127(1):e180-7. doi: 10.1542/peds.2010-0442. — View Citation

Camargo CA Jr, Rifas-Shiman SL, Litonjua AA, Rich-Edwards JW, Weiss ST, Gold DR, Kleinman K, Gillman MW. Maternal intake of vitamin D during pregnancy and risk of recurrent wheeze in children at 3 y of age. Am J Clin Nutr. 2007 Mar;85(3):788-95. — View Citation

Devereux G, Litonjua AA, Turner SW, Craig LC, McNeill G, Martindale S, Helms PJ, Seaton A, Weiss ST. Maternal vitamin D intake during pregnancy and early childhood wheezing. Am J Clin Nutr. 2007 Mar;85(3):853-9. — View Citation

Karatekin G, Kaya A, Salihoglu O, Balci H, Nuhoglu A. Association of subclinical vitamin D deficiency in newborns with acute lower respiratory infection and their mothers. Eur J Clin Nutr. 2009 Apr;63(4):473-7. — View Citation

Urashima M, Segawa T, Okazaki M, Kurihara M, Wada Y, Ida H. Randomized trial of vitamin D supplementation to prevent seasonal influenza A in schoolchildren. Am J Clin Nutr. 2010 May;91(5):1255-60. doi: 10.3945/ajcn.2009.29094. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Percentage of children with recurrent bronchitis	Check that the supplementation of vitamin D of 1,000 units / day decreases the number of recurrent bronchitis	1 year
Primary	Percentage of children with acute bronchitis	Check that the administration of a vitamin D dose of 1,000 U / day decreases the percentage of children with acute bronchitis during the first year of life	1 year
Secondary	Number of episodes of upper respiratory infections reported by parents in the first year of life	Check that the supplementation of vitamin D of 1,000 units / day decreases the number of upper respiratory infections	1 year